Prescription Drug Information: WEGOVY (Page 7 of 9)
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
WEGOVY injection is a clear, colorless solution in a pre-filled, disposable, single-dose pen-injector with an integrated needle. It is supplied in cartons containing 4 pen-injectors in the following packaging configurations:
Total Strength per Total Volume | NDC |
0.25 mg/0.5 mL | 0169-4525-14 |
0.5 mg/0.5 mL | 0169-4505-14 |
1 mg/0.5 mL | 0169-4501-14 |
1.7 mg/0.75 mL | 0169-4517-14 |
2.4 mg/0.75 mL | 0169-4524-14 |
Recommended Storage
Store the WEGOVY single-dose pen in the refrigerator from 2°C to 8°C (36°F to 46°F). If needed, prior to cap removal, the pen can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days. Do not freeze. Protect WEGOVY from light. WEGOVY must be kept in the original carton until time of administration. Discard the WEGOVY pen after use.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Risk of Thyroid C-cell Tumors
Inform patients that semaglutide causes thyroid C-cell tumors in rodents and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea) to their physician [see Boxed Warning and Warnings and Precautions (5.1)].
Acute Pancreatitis
Inform patients of the potential risk for acute pancreatitis. Instruct patients to discontinue WEGOVY promptly and contact their physician if pancreatitis is suspected (severe abdominal pain that may radiate to the back, and which may or may not be accompanied by vomiting) [see Warnings and Precautions (5.2)].
Acute Gallbladder Disease
Inform patients of the risk of acute gallbladder disease. Advise patients that substantial or rapid weight loss can increase the risk of gallbladder disease, but that gallbladder disease may also occur in the absence of substantial or rapid weight loss. Instruct patients to contact their healthcare provider for appropriate clinical follow-up if gallbladder disease is suspected [see Warnings and Precautions ( 5.3)].
Hypoglycemia
Inform patients of the risk of hypoglycemia and educate patients on the signs and symptoms of hypoglycemia. Advise patients with diabetes mellitus on glycemic lowering therapy that they may have an increased risk of hypoglycemia when using WEGOVY and to report signs and/or symptoms of hypoglycemia to their healthcare provider [see Warnings and Precautions (5.4)].
Dehydration and Renal Impairment
Advise patients treated with WEGOVY of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs [see Warnings and Precautions (5.5)].
Hypersensitivity Reactions
Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of semaglutide, the active ingredient in WEGOVY. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking WEGOVY and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.6)].
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes
Inform patients with type 2 diabetes to contact their physician if changes in vision are experienced during treatment with WEGOVY [see Warnings and Precautions ( 5.7)].
Heart Rate Increase
Instruct patients to inform their healthcare providers of palpitations or feelings of a racing heartbeat while at rest during WEGOVY treatment [see Warnings and Precautions (5.8)].
Suicidal Behavior and Ideation
Advise patients to report emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Inform patients that if they experience suicidal thoughts or behaviors, they should stop taking WEGOVY [see Warnings and Precautions (5.9)].
Pregnancy
WEGOVY may cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients who are exposed to WEGOVY during pregnancy to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com [see Use in Specific Populations (8.1)].
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark
For additional information about WEGOVY contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-833-934-6891
Version: 4
WEGOVY® is a registered trademark of Novo Nordisk A/S.
PATENT INFORMATION: http://www.novonordisk-us.com/products/product-patents.html
© 2024 Novo Nordisk
Medication Guide
Medication Guide WEGOVY® (wee-GOH-vee) (semaglutide) injection, for subcutaneous use | |||||
Read this Medication Guide and Instructions for Use before you start using WEGOVY and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. | |||||
What is the most important information I should know about WEGOVY? WEGOVY may cause serious side effects, including:
| |||||
What is WEGOVY?
| |||||
Do not use WEGOVY if:
| |||||
|
| ||||
|
| ||||
| |||||
Before using WEGOVY, tell your healthcare provider if you have any other medical conditions, including if you:
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. | |||||
How should I use WEGOVY?
| |||||
What are the possible side effects of WEGOVY? WEGOVY may cause serious side effects, including:
| |||||
|
| ||||
|
| ||||
| |||||
|
|
| |||
|
|
| |||
|
|
| |||
|
| ||||
|
| ||||
| |||||
|
|
| |||
|
| ||||
The most common side effects of WEGOVY in adults or children aged 12 years and older may include: | |||||
|
|
|
| ||
|
|
|
| ||
|
|
|
| ||
|
|
|
| ||
Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of WEGOVY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088. | |||||
General information about the safe and effective use of WEGOVY. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use WEGOVY for a condition for which it was not prescribed. Do not give WEGOVY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about WEGOVY that is written for health professionals. | |||||
What are the ingredients in WEGOVY? Active Ingredient: semaglutide Inactive Ingredients: disodium phosphate dihydrate, 1.42 mg; sodium chloride, 8.25 mg; water for injection; and hydrochloric acid or sodium hydroxide may be added to adjust pH. | |||||
Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark WEGOVY ® is a registered trademark of Novo Nordisk A/S. PATENT Information: http://novonordisk-us.com/products/product-patents.html © 2024 Novo Nordisk For more information, go to startWegovy.com or call 1-833-Wegovy-1. |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 03/2024
RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.